Personalized Transcranial Magnetic Stimulation (TMS) for Metabolic Dysfunction and Alcohol-Related Liver Disease

Summary

The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, works to treat Metabolic dysfunction-associated and alcohol-associated liver disease (MetALD). The main questions it aims to answer are:

* Can rTMS effectively treat MetALD?
* Is an individualized, precision-targeted rTMS approach more effective than the standard rTMS method?
* What changes in brain activity are associated with the treatment?

Researchers will compare three different types of stimulation:

* Group A: Individualized rTMS targeting a deep brain reward area (the Nucleus Accumbens) based on each participant's brain scan (fMRI).
* Group B: Standard rTMS applied using the traditional "5 cm" rule for positioning.
* Group C: Sham (placebo) rTMS, which mimics the procedure but delivers no significant magnetic stimulation.

Participants will:

* Be randomly assigned to one of the three groups (A, B, or C).
* Undergo an MRI brain scan before starting treatment.
* Receive a total of 20 rTMS sessions, completing at least 4 sessions per week.
* Have additional MRI scans and clinical assessments halfway through and immediately after the treatment course.
* Attend follow-up visits at 1, 3, and 6 months after treatment completion to assess long-term effects.

Conditions

• Liver Diseases, Alcoholic
• Fatty Liver
• Metabolic Syndrome

Interventions

DEVICE

Individually Targeted rTMS

Participants will receive individualized transcranial magnetic stimulation (TMS) based on neuroimaging-guided localization of the nucleus accumbens (NAc). After the first MRI scan, participants will be randomized by an independent researcher responsible for data analysis. The individualized stimulation coordinates will be provided to the TMS operator before treatment. Intervention will be delivered using intermittent theta-burst stimulation (iTBS): the coil will be placed tangentially to the scalp over the individualized target. Stimulation parameters: 90% resting motor threshold (RMT); bursts of 3 pulses at 50 Hz; bursts repeated at 5 Hz; a total of 1800 pulses per session; stimulation duration 570 seconds. Each participant will receive 20 sessions in total, with at least 2 treatment days per week (2 sessions/day, 4 sessions/week). MRI and clinical assessments will be repeated at mid-treatment and after treatment completion, with follow-up clinical evaluations at 1, 3, and 6 months.

DEVICE

Conventional rTMS

Conventional rTMS is applied to the left dorsolateral prefrontal cortex (DLPFC) using the standard 5 cm rule for scalp-based localization. Stimulation is delivered with intermittent theta-burst stimulation (iTBS) at 90% resting motor threshold (RMT), 3 pulses at 50 Hz per burst, repeated at 5 Hz, for a total of 1800 pulses per session. Each session lasts about 570 seconds. Participants complete 20 sessions over 4 weeks, with 2 sessions per day on 2 days per week.

DEVICE

Transcranial Magnetic Stimulation Sham

Sham rTMS is delivered using a sham coil or low-intensity stimulation (10% RMT) to mimic the clicking sounds and scalp sensations of active rTMS without producing cortical activation. The sham sessions are matched to the active treatment in frequency, duration, and total number: 20 sessions in 4 weeks (2 sessions/day, 2 days/week, 570 seconds per session).

Sponsors & Collaborators

• The Affiliated Hospital of Hangzhou Normal University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2027-08-31

Completion

2027-12-31

Countries

• China

Study Locations